Heparin-induced Thrombocytopenia

• FDA approval · 2023-08-01
  FDA Approved: ARGATROBAN — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Argatroban from Mylan Institutional LLC under ANDA 202626, expanding the use of this generic…

• FDA approval · 2023-07-31
  FDA Approved: ARGATROBAN — Original Application (Mullan Pharmaceutical Inc.)

  The FDA approved a generic version of argatroban from Mullan Pharmaceutical Inc. for anticoagulation in patients with heparin-induced thromb…

• FDA approval · 2021-06-07
  FDA Approved: ARGATROBAN — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original application for argatroban, authorizing its use as an anticoagulant for heparin-induced throm…

• FDA approval · 2021-01-21
  FDA Approved: ARGATROBAN — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA's Argatroban under an Original Application (ANDA214235), making a generic direct thrombin inhibitor availabl…

• FDA approval · 2018-12-21
  FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for BIVALIRUDIN from Civica, Inc., resulting in an approved update to the NDA.

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• FDA approval · 2018-11-27
  FDA Approved: ARGATROBAN — Original Application (Eugia US LLC)

  FDA approved Argatroban under an Original Application (NDA209552) by Eugia US LLC, establishing its use as a direct thrombin inhibitor for p…

• FDA approval · 2018-07-27
  FDA Approved: BIVALIRUDIN — Original Application (Eugia US LLC)

  FDA approved the original application for BIVALIRUDIN by Eugia US LLC, granting a generic version of the anticoagulant for approved indicati…

• FDA approval · 2018-06-01
  FDA Approved: BIVALIRUDIN — Original Application (Mylan Institutional LLC)

  FDA approved the original abbreviated new drug application for bivalirudin from Mylan Institutional LLC, enabling the marketing of a generic…

• FDA approval · 2017-05-22
  FDA Approved: ARGATROBAN — Original Application (Gland Pharma Limited)

  FDA approved a generic injectable anticoagulant Argatroban from Gland Pharma Limited under Original Application (ANDA205570) for use in adul…

• FDA approval · 2016-05-25
  FDA Approved: ARGATROBAN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Argatroban from Fresenius Kabi USA, LLC. This action constitutes a supplemental approval rather …

• FDA approval · 2016-03-21
  FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)

  FDA approved a Civica, Inc.-submitted supplemental application for Bivalirudin, updating its regulatory status for use as an anticoagulant. …

• FDA approval · 2015-03-23
  FDA Approved: ARGATROBAN — Original Application (Fresenius Kabi USA, LLC)

  FDA approves Argatroban through an Original Application for Fresenius Kabi USA, marking a first-time approval of this injectable anticoagula…

• FDA approval · 2014-10-16
  FDA Approved: ARGATROBAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental NDA for Argatroban from Hikma Pharmaceuticals USA Inc., granting additional authorization under a supplemental a…

• FDA approval · 2014-06-30
  FDA Approved: ARGATROBAN — Original Application (Mylan Institutional LLC)

  FDA approved a generic Argatroban from Mylan Institutional LLC under ANDA 202626 for use as an anticoagulant in adults with heparin-induced …

• FDA approval · 2014-06-30
  FDA Approved: ARGATROBAN — Original Application (Par Health USA, LLC)

  The FDA approved a generic Argatroban product under an Original Application for Par Health USA, LLC.

• FDA approval · 2013-02-13
  FDA Approved: ARGATROBAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Argatroban submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2012-01-05
  FDA Approved: ARGATROBAN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s Argatroban on an Original Application, providing an injectable direct thrombin inhibitor for p…